اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
BUTOCONAZOLE NITRATE از شرکت PADAGIS US
New Drug Application (NDA): 019881
Company: PADAGIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUTOCONAZOLE NITRATE | BUTOCONAZOLE NITRATE | 2% | CREAM;VAGINAL | Discontinued |
None |
No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/07/1997 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/10/2012 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/24/2003 | SUPPL-9 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19881slr009_gynazole_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19881slr009ltr.pdf |
||
| 08/02/2002 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/28/2000 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/01/2000 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/12/2000 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/2003 | SUPPL-2 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019881s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19881slr002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/24/2003 | SUPPL-9 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19881slr009_gynazole_lbl.pdf | |
| 04/30/2003 | SUPPL-2 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019881s002lbl.pdf |
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